| CTRI Number |
CTRI/2022/12/048375 [Registered on: 21/12/2022] Trial Registered Prospectively |
| Last Modified On: |
09/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To study quality of recovery in patients undergoing intracranial and spinal surgery using QoR-40 score |
|
Scientific Title of Study
|
To study the quality of recovery in patients following intracranial and spinal surgery using the QoR-40 score and assess the patient’s recovery profile |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr PRIYA |
| Designation |
Senior resident, neuroanestheia |
| Affiliation |
|
| Address |
2nd floor, faculty building,NIMHANS,
Hombegowda nagar Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
8884665691 |
| Fax |
|
| Email |
pakalpriya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhadrinarayana |
| Designation |
Professor, deptt of Neuroanestheia |
| Affiliation |
|
| Address |
Neuroanestheia, NIMHANS
Hombegowda nagar Bengaluru
Neuroanestheia, NIMHANS
Hombegowda nagar Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9448084257 |
| Fax |
|
| Email |
n_bhadri@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PRIYA |
| Designation |
Senior resident, neuroanestheia |
| Affiliation |
|
| Address |
2nd floor, faculty building NIMHANS
Hombegowda nagar Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
8884665691 |
| Fax |
|
| Email |
pakalpriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| National institute of mental health and neurosciences
Hombegowda nagar Bengaluru-560029, Karnataka |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priya |
national institute of mental health and neurosciences |
Deptt of Neuroanestheia, 3rd floor faculty building. national institute of mental health and neurosciences, Hombegowda nagara, Bengaluru-560029
Bangalore
KARNATAKA |
8884665691
pakalpriya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing elective neurosurgical procedures who are fully conscious
ASA I-III |
|
| ExclusionCriteria |
| Details |
1.Preoperative disturbance of consciousness
2.Patients with disease that could impact post-operative recovery (e.g.,kyphoscoliosis, chronic kidney disease, or severe psychological or mental
illness) or pregnancy
3.Patient with a life-threatening condition (ASA physical status IV or V).
4.Refusal of consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of recovery (QoR-40) score |
preoperative
postoperative day1, 7, 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Preoperative status and comorbidities affecting the quality of recovery
2. Intraoperative and postoperative events influencing the quality of recovery
3. if there is any gender difference which affects the recovery profile |
preoperative
postoperative day1, 7, 30 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "272"
Final Enrollment numbers achieved (India)="272" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/12/2022 |
| Date of Study Completion (India) |
14/06/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
14/06/2023 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective, observational study conducted to evaluate quality of recovery in patients undergoing elective neurosurgical procedures (intracranial and spinal surgeries) using QoR-40 score and to study the patients preoperative status, intraoperative factors whether have any influence on the patients recovery profile. The study will be conducted over period of 6 months in elective neurosurgical patients admitted in NIMHANS, Bengaluru. The
primary outcome measures will be QoR-40 score and VAS score measured till 30days from surgery . The
secondary outcomes will be any comorbidities, intraoperative/postoperative insults influencing on recovery profile measured till 30days postoperatively. |